Percutaneous papillary muscle relocation

ABSTRACT

A system for treating mitral regurgitation may include an outer sheath having a lumen extending to a distal end of the outer sheath, an intermediate sheath slidably disposed within the lumen of the outer sheath, the intermediate sheath having a lumen extending to a distal end of the intermediate sheath, and an inner sheath slidably disposed within the lumen of the intermediate sheath, wherein the inner sheath includes a first anchor disposed within a lumen of the inner sheath, the first anchor being configured to penetrate and secure to a first papillary muscle. The intermediate sheath may include a tissue grasping mechanism at the distal end of the intermediate sheath, the tissue grasping mechanism being configured to hold and stabilize the first papillary muscle for penetration and securement of the first anchor to the first papillary muscle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/419,640, filed May 22, 2019, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Application Ser. No.62/675,118, filed May 22, 2018, the entirety of which is incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices and methods for usingmedical devices. More particularly, the present disclosure pertains toaspects of medical devices and/or means to deliver and release medicaldevices for percutaneously treating mitral regurgitation by relocatingthe papillary muscles of the heart.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, surgical and/or intravascular use. Some ofthese devices include guidewires, catheters, medical device deliverysystems (e.g., for stents, grafts, replacement valves, occlusive medicaldevices, etc.), and the like. These devices are manufactured by any oneof a variety of different manufacturing methods and may be usedaccording to any one of a variety of methods. There is an ongoing needto provide alternative medical devices as well as alternative methodsfor manufacturing and/or using medical devices.

SUMMARY

In a first aspect, a system for treating mitral regurgitation maycomprise an outer sheath having a lumen extending to a distal end of theouter sheath, an intermediate sheath slidably disposed within the lumenof the outer sheath, the intermediate sheath having a lumen extending toa distal end of the intermediate sheath, and an inner sheath slidablydisposed within the lumen of the intermediate sheath, wherein the innersheath includes a first anchor disposed within a lumen of the innersheath, the first anchor being configured to penetrate and secure to afirst papillary muscle. The intermediate sheath may include a tissuegrasping mechanism at the distal end of the intermediate sheath, thetissue grasping mechanism being configured to hold and stabilize thefirst papillary muscle for penetration and securement of the firstanchor to the first papillary muscle.

In addition or alternatively, and in a second aspect, the tissuegrasping mechanism includes a first prong and a second prong eachattached to the distal end of the intermediate sheath. The first prongand the second prong may be configured to shift between a graspingconfiguration and an open configuration, the first prong and the secondprong being biased toward the open configuration when unconstrained.

In addition or alternatively, and in a third aspect, in the openconfiguration, a gap between a distal end of the first prong and adistal end of the second prong is greater than an outer extent of theouter sheath.

In addition or alternatively, and in a fourth aspect, relativetranslation of the outer sheath and the tissue grasping mechanism towardeach other urges the first prong and the second prong toward thegrasping configuration.

In addition or alternatively, and in a fifth aspect, the intermediatesheath includes an actuator element extending proximally from the tissuegrasping mechanism to an actuation position proximate a proximal end ofthe intermediate sheath.

In addition or alternatively, and in a sixth aspect, tension applied tothe actuator element urges the first prong and the second prong towardthe grasping configuration.

In addition or alternatively, and in a seventh aspect, the tissuegrasping mechanism includes a curved member attached to the distal endof the intermediate sheath, the curved member being configured to extendaround a majority of a circumference of the first papillary muscle.

In addition or alternatively, and in an eighth aspect, distaladvancement of the inner sheath relative to the curved member until adistal end of the inner sheath is positioned against the first papillarymuscle grasps the first papillary muscle to facilitate penetration ofthe first anchor into the first papillary muscle through the distal endof the inner sheath.

In addition or alternatively, and in a ninth aspect, the inner sheathincludes a port extending through a side wall of the inner sheathproximate a distal end of the inner sheath, and at least one orientationmarker positioned adjacent the port for determining an orientation ofthe port relative to the first papillary muscle. Distal advancement ofthe inner sheath relative to the curved member until the distal end ofthe inner sheath is positioned adjacent the first papillary musclegrasps the first papillary muscle to facilitate penetration of the firstanchor into the first papillary muscle through the port at an anglegenerally perpendicular to a surface of the first papillary muscle beingpenetrated.

In addition or alternatively, and in a tenth aspect, the distal end ofthe inner sheath is a closed distal end.

In addition or alternatively, and in an eleventh aspect, a system fortreating mitral regurgitation may comprise an outer sheath having alumen extending to a distal end of the outer sheath, an intermediatesheath slidably disposed within the lumen of the outer sheath, theintermediate sheath having a lumen extending to a distal end of theintermediate sheath, an inner sheath slidably disposed within the lumenof the intermediate sheath, wherein the inner sheath includes a firstanchor disposed within a lumen of the inner sheath, the first anchorbeing configured to penetrate and secure to a first papillary muscle,wherein the intermediate sheath includes a tissue grasping mechanism atthe distal end of the intermediate sheath, the tissue grasping mechanismbeing configured to hold and stabilize the first papillary muscle forpenetration and securement of the first anchor to the first papillarymuscle, and a second anchor advanceable through the lumen of the innersheath, the second anchor being configured to penetrate and secure to asecond papillary muscle.

In addition or alternatively, and in a twelfth aspect, the first anchorand the second anchor are connectable to each other.

In addition or alternatively, and in a thirteenth aspect, the firstanchor and the second anchor are configured to be connected to eachother after deployment from the inner sheath.

In addition or alternatively, and in a fourteenth aspect, the firstanchor and the second anchor are connected to each other by a tetheringelement.

In addition or alternatively, and in a fifteenth aspect, the tissuegrasping mechanism is configured to hold and stabilize the secondpapillary muscle for penetration and securement of the second anchor tothe second papillary muscle.

In addition or alternatively, and in a sixteenth aspect, a method fortreating mitral regurgitation may comprise:

advancing a distal end of an outer sheath intravascularly to a leftventricle of a heart, the outer sheath having a lumen extending to thedistal end of the outer sheath;

wherein an intermediate sheath is slidably disposed within the lumen ofthe outer sheath, the intermediate sheath having a lumen extending to adistal end of the intermediate sheath and a tissue grasping mechanismdisposed at the distal end of the intermediate sheath; and

wherein an inner sheath is slidably disposed within the lumen of theintermediate sheath;

grasping a first papillary muscle of the left ventricle using the tissuegrasping mechanism, the tissue grasping mechanism being configured tohold and stabilize the first papillary muscle for penetration of a firstanchor into the first papillary muscle from the inner sheath;

advancing the first anchor into the first papillary muscle from within alumen of the inner sheath, the first anchor being configured topenetrate and secure to the first papillary muscle of the leftventricle;

grasping a second papillary muscle of the left ventricle using thetissue grasping mechanism at the distal end of the intermediate sheath,the tissue grasping mechanism being configured to hold and stabilize thesecond papillary muscle for penetration of a second anchor into thesecond papillary muscle from the inner sheath;

advancing the second anchor into the second papillary muscle from withinthe lumen of the inner sheath, the second anchor being configured topenetrate and secure to the second papillary muscle of the leftventricle; and

releasing the second papillary muscle from the tissue graspingmechanism, wherein a tethering element extends from the first anchor tothe second anchor to connect and reposition the first papillary musclerelative to the second papillary muscle.

In addition or alternatively, and in a seventeenth aspect, the firstanchor and the second anchor each include an eyelet, and the tetheringelement extends between the eyelet of the first anchor and the eyelet ofthe second anchor.

In addition or alternatively, and in an eighteenth aspect, at least aportion of each of the first anchor and the second anchor is configuredto extend transversely relative to the tethering element whenunconstrained by the inner sheath.

In addition or alternatively, and in a nineteenth aspect, at least oneof the first anchor and the second anchor includes a plurality of anchorlegs extending from the eyelet to free ends, wherein the plurality ofanchor legs is configured to shift from a delivery configuration whenconstrained by the inner sheath to a deployed configuration whenunconstrained by the inner sheath. In the delivery configuration, thefree ends of the plurality of anchor legs may point in a distaldirection, and in the deployed configuration the free ends of theplurality of anchor legs may point in a proximal direction.

In addition or alternatively, and in a twentieth aspect, the methodfurther includes translating the first papillary muscle closer to thesecond papillary muscle by tensioning the tethering element between thefirst anchor and the second anchor.

The above summary of some embodiments, aspects, and/or examples is notintended to describe each embodiment or every implementation of thepresent disclosure. The figures and the detailed description whichfollows more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a partial cut-away view of an example heart having a“distended” left ventricle and/or experiencing mitral regurgitation;

FIG. 2 illustrates aspects of an example method of treating mitralregurgitation;

FIGS. 3-4 illustrate an example configuration of a mitral regurgitationtreatment system;

FIGS. 5-6 illustrate an example configuration of a mitral regurgitationtreatment system;

FIGS. 7-8 illustrate an example configuration of a mitral regurgitationtreatment system;

FIG. 9 illustrates an alternative configuration of the mitralregurgitation treatment system of FIGS. 7-8 ;

FIG. 10 illustrates an example configuration of a mitral regurgitationtreatment system;

FIGS. 11 and 12 illustrate an example configuration of a mitralregurgitation treatment system;

FIG. 13 illustrates an alternative configuration of the mitralregurgitation treatment system of FIGS. 11-12 ;

FIGS. 14 and 15 illustrate example configurations of the mitralregurgitation treatment system of FIG. 9 ;

FIG. 16 illustrates an example anchor in a delivery configuration;

FIG. 17 illustrates the example anchor of FIG. 16 in a deployedconfiguration;

FIG. 18 illustrates an alternative anchor in the delivery configuration;and

FIGS. 19-22 illustrate further aspects of the example method of treatingmitral regurgitation.

While aspects of the disclosure are amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed invention. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed invention. However, in the interest ofclarity and ease of understanding, while every feature and/or elementmay not be shown in each drawing, the feature(s) and/or element(s) maybe understood to be present regardless, unless otherwise specified.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosedinvention are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. Additionally,not all instances of some elements or features may be shown in eachfigure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “upstream”, “downstream”,“inflow”, and “outflow” refer to a direction of fluid flow within alumen, such as a body lumen, a blood vessel, or within a device. Stillother relative terms, such as “axial”, “circumferential”,“longitudinal”, “lateral”, “radial”, etc. and/or variants thereofgenerally refer to direction and/or orientation relative to a centrallongitudinal axis of the disclosed structure or device.

The terms “extent” and/or “maximum extent” may be understood to mean agreatest measurement of a stated or identified dimension, while the term“minimum extent” may be understood to mean a smallest measurement of astated or identified dimension. For example, “outer extent” may beunderstood to mean a maximum outer dimension, “radial extent” may beunderstood to mean a maximum radial dimension, “longitudinal extent” maybe understood to mean a maximum longitudinal dimension, etc. Eachinstance of an “extent” may be different (e.g., axial, longitudinal,lateral, radial, circumferential, etc.) and will be apparent to theskilled person from the context of the individual usage. Generally, an“extent” or “maximum extent” may be considered a greatest possibledimension measured according to the intended usage. Alternatively, a“minimum extent” may be considered a smallest possible dimensionmeasured according to the intended usage. In some instances, an “extent”may generally be measured orthogonally within a plane and/orcross-section, but may be, as will be apparent from the particularcontext, measured differently—such as, but not limited to, angularly,radially, circumferentially (e.g., along an arc), etc.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments, alterations of and deviations frompreviously-used numerical nomenclature may be made in the interest ofbrevity and clarity. That is, a feature identified as a “first” elementmay later be referred to as a “second” element, a “third” element, etc.or may be omitted entirely, and/or a different feature may be referredto as the “first” element. The meaning and/or designation in eachinstance will be apparent to the skilled practitioner.

Diseases and/or medical conditions that impact the cardiovascular systemare prevalent throughout the world. Some mammalian hearts (e.g., human,etc.) include four heart valves: a tricuspid valve 12, a pulmonary valve14, an aortic valve 16, and a mitral valve 18, as seen in an exampleheart 10 illustrated in FIG. 1 . The purpose of the heart valves is tocontrol blood flow into the heart 10 from the inferior vena cava 24and/or the superior vena cava 26, through the heart 10, and out of theheart 10 into the major blood vessels connected to the heart 10, such asthe aorta 20, the pulmonary artery 22, for example. Each heart valve mayhave a plurality of valve leaflets configured to shift between an openconfiguration permitting fluid flow through the heart valve in anantegrade direction, and a closed configuration wherein free edges ofthe valve leaflets coapt to substantially prevent fluid flow through theheart valve in a retrograde direction. The heart 10 may also include aleft atrium 30, a left ventricle 40, a right atrium 50, and a rightventricle 60. The left ventricle 40 may include a first papillary muscle42 attached to and/or extending from a wall of the left ventricle 40, asecond papillary muscle 44 attached to and/or extending from the wall ofthe left ventricle 40, and a plurality of chordae 46 connecting thefirst papillary muscle 42 and the second papillary muscle 44 to theleaflets of the mitral valve 18. In a normally functioning heart valve,blood is permitted to pass or flow downstream through the heart valve(e.g., from an atrium to a ventricle, from a ventricle to an artery,etc.) when the heart valve is open (e.g., during diastole), and when theheart valve is closed (e.g., during systole), blood is prevented frompassing or flowing back upstream through the heart valve (e.g., from aventricle to an atrium, etc.).

In some instances, when regurgitation (e.g., mitral regurgitation)occurs, a heart valve (e.g., the mitral valve 18) fails to open and/orclose properly such that blood is permitted to pass or flow backupstream through the heart valve (e.g., from a ventricle to an atrium,etc.). In some cases, the defective heart valve may have leaflets thatmay not close, or may not be capable of closing, completely. In someinstances, secondary or functional mitral regurgitation may be asecondary effect of left ventricular dysfunction, where left ventriculardilatation and/or distension caused by ischemic or idiopathiccardiomyopathy, for example, results in annular dilatation and/ordistension of the left ventricle 40 and papillary muscle displacementwith subsequent leaflet tethering and insufficient coaptation of themitral leaflets during systole, as seen in FIG. 1 for example. As theleft ventricle 40 dilates and/or distends outward, the first and secondpapillary muscles 42/44 are displaced outward and/or away from themitral valve 18. Displacement of the first and second papillary muscles42/44 adds tension to the chordae 46 connecting the first and secondpapillary muscles 42/44 to the mitral valve leaflets, and/or changes thetension on the chordae 46 with respect to a directional vector of thetension, resulting in leaflet tethering and/or insufficient coaptationof the mitral leaflets during systole.

Disclosed herein are apparatus, medical devices, and/or methods that maybe used to diagnose, treat, and/or repair a portion of thecardiovascular system. One possible remedy is an annular reductionprocedure that may be performed to reduce an overall extent of thedefective heart valve to bring the heart valve leaflets closer together.In some procedures, the annular reduction procedure may be performed inconjunction with a sub-valvular repair technique involving relocation ofthe papillary muscles to reduce leaflet tethering, thereby permittingthe heart valve leaflets to more properly close the defective heartvalve the passage of blood. The disclosed mitral regurgitation treatmentmethod(s) and associated medical device(s) may be performed/usedpercutaneously via minimally-invasive intravascular techniques, or in analternative method, using open-heart surgical methods. The device(s) andmethod(s) disclosed herein may also provide a number of additionaldesirable features and/or benefits as described in more detail below.For the purpose of this disclosure, the discussion below is directedtoward repairing the mitral valve 18 and will be so described in theinterest of brevity. This, however, is not intended to be limiting asthe skilled person will recognize that the following discussion may alsoapply to the aortic valve 16 or another heart valve (e.g., the tricuspidvalve 12, the pulmonary valve 14, etc.) with no or minimal changes tothe structure and/or scope of the disclosure.

A mitral regurgitation treatment system may reposition the firstpapillary muscle 42 and/or the second papillary muscle 44 relative toeach other, relative to the wall of the left ventricle 40, and/orrelative to the mitral valve 18 and/or the annulus of the mitral valve18. In some embodiments, the mitral regurgitation treatment system maypull the first papillary muscle 42 closer to the second papillary muscle44. In some embodiments, pulling the first papillary muscle 42 closer tothe second papillary muscle 44 may also relocate the wall of the leftventricle 40, thereby reducing and/or eliminating the magnitude ofdilatation and/or distension of the left ventricle 40, which also servesto reduce tension on the chordae 46, reduce leaflet tethering, andimproves coaptation of the mitral leaflets during systole. In someembodiments, pulling the first papillary muscle 42 closer to the secondpapillary muscle 44 may have limited effect upon the wall of the leftventricle 40 but may still reduce tension on the chordae 46, reduceleaflet tethering, and improves coaptation of the mitral leaflets duringsystole due to relocation of the first papillary muscle 42 and thesecond papillary muscle 44 closer to each other and/or the mitral valve18.

FIG. 2 illustrates selected aspects of an example method of treatingmitral regurgitation. In at least some embodiments, the method mayinclude advancing a distal end 102 of an outer sheath 100 of a mitralregurgitation treatment system intravascularly to the left ventricle 40of the heart 10. In some embodiments, the outer sheath 100 of the mitralregurgitation treatment system may be inserted through a femoral arteryand advanced in a retrograde direction (e.g., upstream) through theaorta 20 and the aortic valve 16 into the left ventricle 40 of the heart10. Alternative percutaneous approaches, including but not limited totransseptal access, as well as additional alternative methods includingbut not limited to an apical approach, are also contemplated.

The outer sheath 100 may have a lumen extending to the distal end 102 ofthe outer sheath 100. In some embodiments, the lumen may extendcompletely through the outer sheath 100 to a proximal end of the outersheath 100. Alternatively, in some embodiments, a proximal end of thelumen may exit the outer sheath 100 distal of the proximal end of theouter sheath 100. In some embodiments, the distal end 102 and/or adistal portion of the outer sheath 100 may be steerable to facilitatenavigation and treatment procedures. The distal end 102 and/or thedistal portion of the outer sheath 100 may be steerable to direct anopening from the lumen toward the first papillary muscle 42 and/or thesecond papillary muscle 44, as discussed herein. The proximal end of theouter sheath 100 may be disposed and/or be configured to be manipulatedby a user outside of a patient's anatomy.

In some embodiments, the mitral regurgitation treatment system mayinclude an intermediate sheath 110 slidably disposed within the lumen ofthe outer sheath 100. The intermediate sheath 110, a proximal portion ofwhich may be seen in FIG. 2 adjacent the proximal end of the outersheath 100, may have a lumen extending to a distal end 112 of theintermediate sheath 110 and a tissue grasping mechanism 120 disposed atthe distal end 112 of the intermediate sheath 110, as seen in FIG. 3 forexample. Additional and/or alternative forms for the tissue graspingmechanism 120 may be seen in FIGS. 5 (e.g., tissue grasping mechanism220), 7 (e.g., tissue grasping mechanism 320), 12 (e.g., tissue graspingmechanism 290), and 13 (e.g., tissue grasping mechanism 294), and willbe discussed in more detail herein. It should be understood that whileaspects of the tissue grasping mechanism(s) are illustrated with respectto the first papillary muscle 42 in the interest of brevity, any and/orall aspects of the tissue grasping mechanism(s) 120/220/320/290/294 mayapply equally with respect to the second papillary muscle 44 and/or anyprocedures or method steps occurring with respect thereto.

In some embodiments, the tissue grasping mechanism 120 may include afirst prong 122 and a second prong 124 each fixedly attached to thedistal end 112 of the intermediate sheath 110, as seen in FIG. 3 forexample. In some embodiments, the first prong 122 and the second prong124 may be integrally formed with the intermediate sheath 110. In someembodiments, the first prong 122 and the second prong 124 may each be atleast partially embedded within a wall of the intermediate sheath 110.In some embodiments, a proximal end of each of the first prong 122 andthe second prong 124 may be attached, affixed, and/or secured to anouter surface of the intermediate sheath 110. Various known means ofattachment may be used, including but not limited to, adhesives, shrinkwrap, welding, mechanical attachment, etc. The first prong 122 and thesecond prong 124 of the tissue grasping mechanism 120 may be configuredto shift between a grasping configuration, shown in FIG. 4 for example,and an open configuration (e.g., FIG. 3 ). The first prong 122 and thesecond prong 124 of the tissue grasping mechanism 120 may be biasedtoward the open configuration when unconstrained, such as when disposedoutside of the outer sheath 100, for example. In at least someembodiments, the first prong 122 and the second prong 124 may beself-biased toward the open configuration when unconstrained.

In the open configuration, a gap 125A between a distal end of the firstprong 122 and a distal end of the second prong 124, and moreparticularly a gap 125B between a first barb 126 on the first prong 122extending toward the second prong 124 and a second barb 127 on thesecond prong 124 extending toward the first prong 122, is greater thanan outer extent of the outer sheath 100 measured across the gap125A/125B and/or normal to a longitudinal axis of the outer sheath 100.In the open configuration, the gap 125A/125B may permit the first prong122 and the second prong 124 of the to fit around and/or encompass atleast a portion of the first papillary muscle 42 and/or the secondpapillary muscle 44, as seen in FIG. 3 .

In the grasping configuration, the tissue grasping mechanism 120 may beconfigured to hold and stabilize the first papillary muscle 42 and/orthe second papillary muscle 44, as seen in FIG. 4 . In order to achievethe grasping configuration, the outer sheath 100 may be advanceddistally while the intermediate sheath 110 and/or the tissue graspingmechanism 120 is maintained in a static position, and/or theintermediate sheath 110 and/or the tissue grasping mechanism 120 may beretracted proximally while the outer sheath 100 is maintained in astatic position, such that relative translation between the outer sheath100 and the intermediate sheath 110 and/or the tissue grasping mechanism120 moves the distal end 102 of the outer sheath 100 over the firstprong 122 and the second prong 124 of the tissue grasping mechanism 120,thereby urging the first prong 122 and the second prong 124 towards eachother and/or the grasping configuration. In the grasping configuration,the first papillary muscle 42 and/or the second papillary muscle 44 maybe pinched, squeezed, and/or otherwise held between the first prong 122and the second prong 124 of the tissue grasping mechanism 120. An anchormay then be inserted into and/or through the papillary muscle from aninner sheath 130, as described herein.

FIGS. 5 and 6 illustrate an alternative configuration of a tissuegrasping mechanism 220 disposed at the distal end 112 of theintermediate sheath 110. In some embodiments, the tissue graspingmechanism 220 may include a first prong 222 and a second prong 224configured to shift between a grasping configuration, shown in FIG. 6for example, and an open configuration (e.g., FIG. 5 ). The first prong222 and the second prong 224 of the tissue grasping mechanism 220 may bebiased toward the open configuration when unconstrained, such as whendisposed outside of the outer sheath 100, for example. In at least someembodiments, the first prong 222 and the second prong 224 may beself-biased toward the open configuration when unconstrained.

In the open configuration, a gap 225A between a distal end of the firstprong 222 and a distal end of the second prong 224, and moreparticularly a gap 225B between a first barb 226 on the first prong 222extending toward the second prong 224 and a second barb 227 on thesecond prong 224 extending toward the first prong 222, is greater thanan outer extent of the outer sheath 100 measured across the gap225A/225B and/or normal to a longitudinal axis of the outer sheath 100.In the open configuration, the gap 225A/225B may permit the first prong222 and the second prong 224 of the to fit around and/or encompass atleast a portion of the first papillary muscle 42 and/or the secondpapillary muscle 44, as seen in FIG. 5 .

In the grasping configuration, the tissue grasping mechanism 220 may beconfigured to hold and stabilize the first papillary muscle 42 and/orthe second papillary muscle 44, as seen in FIG. 6 . In order to achievethe grasping configuration, the outer sheath 100 may be maintained in astatic position, and an actuator element 228 extending proximally fromthe tissue grasping mechanism 120 to an actuation position (e.g., FIG. 2) proximate a proximal end of the intermediate sheath 110 may beretracted proximally, such that relative translation between the outersheath 100 and actuator element 228 and/or the tissue grasping mechanism220 urges the first prong 222 and the second prong 224 of the tissuegrasping mechanism 220 towards each other and/or the graspingconfiguration. For example, tension applied to the actuator element 228may urge the first prong 222 and the second prong 224 towards each otherand/or the grasping configuration by translating the tissue graspingmechanism 220 into the distal end 112 of the intermediate sheath 110.Alternatively, the first prong 222 and the second prong 224 may behingedly connected proximate a proximal end of the first prong 222 andthe second prong 224, and the actuator element 228 may be connected toeach of the first prong 222 and the second prong 224 distal of thehinged connection such that tension applied to the actuator element 228may urge the first prong 222 and the second prong 224 towards each otherand/or the grasping configuration by causing the first prong 222 and thesecond prong 224 to pivot towards each other and/or toward the graspingconfiguration at the hinged connection. In the grasping configuration,the first papillary muscle 42 and/or the second papillary muscle 44 maybe pinched, squeezed, and/or otherwise held between the first prong 222and the second prong 224 of the tissue grasping mechanism 220.

An anchor may then be inserted into and/or through the papillary musclefrom an inner sheath, as described herein.

In another alternative configuration, the intermediate sheath 110 mayinclude a tissue grasping mechanism 320 at the distal end 112 of theintermediate sheath 110. The tissue grasping mechanism 320 may include acurved member 322 fixedly attached to the distal end 112 of theintermediate sheath 110, as seen in FIG. 7 for example. In someembodiments, the curved member 322 may be integrally formed with theintermediate sheath 110. In some embodiments, the curved member 322 maybe at least partially embedded within a wall of the intermediate sheath110. In some embodiments, a proximal end of the curved member 322 may beattached, affixed, and/or secured to an outer surface of theintermediate sheath 110. Various known means of attachment may be used,including but not limited to, adhesives, shrink wrap, welding,mechanical attachment, etc.

The curved member 322 may be configured to shift between a deliveryconfiguration, wherein the curved member 322 is constrained by andstraightened by the outer sheath 100, and a curved configuration,wherein when the curved member 322 is unconstrained, the curved member322 is biased towards the curved configuration and/or shape, asillustrated in FIG. 7 for example. In at least some embodiments, thecurved member 322 may be self-biased towards the curved configuration.For example, in some embodiments, the curved member 322 may be formedfrom a shape memory alloy and/or may be heat set to the curvedconfiguration and/or shape. As the intermediate sheath 110 is advancedthrough and/or out of the distal end 102 of the outer sheath 100, thecurved member 322 may be deployed and allowed/permitted to shift towardsthe curved configuration. During use, the intermediate sheath 110 and/orthe curved member 322 may be maneuvered within the left ventricle 40 toposition the curved member 322 around the first papillary muscle 42and/or the second papillary muscle 44, using a suitable imagingtechnique (e.g., ultrasound, etc.). The curved member 322 may be adaptedand/or configured to extend around a majority of a circumference of thefirst papillary muscle 42 and/or the second papillary muscle 44 in thecurved configuration.

In order to fully secure the first papillary muscle 42 and/or the secondpapillary muscle 44, an inner sheath 130 slidably disposed within thelumen of the intermediate sheath 110 may be extended out of the distalend 112 of the intermediate sheath 110 and into contact with an outersurface of the first papillary muscle 42 and/or the second papillarymuscle 44, as seen in FIG. 8 for example. The first papillary muscle 42and/or the second papillary muscle 44 may be pinched, squeezed, and/orotherwise held between inner sheath 130 and the curved member 322.

In some embodiments, distal advancement of the inner sheath 130 relativeto the curved member 322 and/or the intermediate sheath 110 until adistal end 132 of the inner sheath 130 is positioned against the outersurface of the first papillary muscle 42 and/or the second papillarymuscle 44 may grasp the first papillary muscle 42 and/or the secondpapillary muscle 44 to facilitate penetration of an anchor into thefirst papillary muscle 42 and/or the second papillary muscle 44 throughan opening at the distal end 132 of the inner sheath 130, as discussedherein. A central longitudinal axis of the inner sheath 130 and/or theopening at the distal end 132 of the inner sheath 130 may be orientedsubstantially perpendicular to the outer surface of the first papillarymuscle 42 and/or the second papillary muscle 44.

In an alternative configuration, the inner sheath 130 may include a port136 extending through a side wall of the inner sheath 130 proximate thedistal end 132 of the inner sheath 130, as seen in FIG. 9 for example,instead of and/or in addition to the opening at the distal end 132 ofthe inner sheath 130. In some embodiments, the distal end 132 of theinner sheath 130 may be a closed distal end. In some embodiments, distaladvancement of the inner sheath 130 relative to the curved member 322and/or the intermediate sheath 110 until the distal end 132 of the innersheath 130 is positioned adjacent the first papillary muscle 42 and/orthe second papillary muscle 44 may grasp the first papillary muscle 42and/or the second papillary muscle 44 to facilitate penetration of ananchor into the first papillary muscle 42 and/or the second papillarymuscle 44 through the port 136 at an angle generally perpendicular to asurface of the first papillary muscle 42 and/or the second papillarymuscle 44 being penetrated, as discussed herein. In at least someembodiments, the central longitudinal axis of the inner sheath 130 maybe oriented substantially parallel to the outer surface of the firstpapillary muscle 42 and/or the second papillary muscle 44 beingpenetrated such that the port 136 generally abuts the outer surface ofthe first papillary muscle 42 and/or the second papillary muscle 44being penetrated.

In another example configuration of the mitral regurgitation treatmentsystem, a positioning sheath 180 may be slidably disposed within thelumen of the intermediate sheath 110. The positioning sheath 180 mayinclude a distal end 182 and a port 186 extending through a side wall ofthe positioning sheath 180 proximate the distal end 182 of thepositioning sheath 180, as seen in FIG. 10 for example. In at least someembodiments, the distal end 182 of the positioning sheath 180 may be aclosed distal end. The inner sheath 130 may be slidably disposed withina lumen of the positioning sheath 180. In at least some embodiments, thelumen of the positioning sheath 180 and/or the port 186 of thepositioning sheath 180 may be configured to direct the distal end 132 ofthe inner sheath 130 toward and/or into contact with the first papillarymuscle 42 and/or the second papillary muscle 44 upon advancement of theinner sheath 130 relative to the positioning sheath 180, theintermediate sheath 110, and/or the curved member 322. In someembodiments, the positioning sheath 180 may be configured to cooperatewith the inner sheath 130 to facilitate penetration of an anchor intothe first papillary muscle 42 and/or the second papillary muscle 44through an opening at the distal end 132 of the inner sheath 130 at anangle generally perpendicular to a surface of the first papillary muscle42 and/or the second papillary muscle 44 being penetrated, as discussedherein. In at least some embodiments, a central longitudinal axis of thepositioning sheath 180 may be oriented substantially parallel to theouter surface of the first papillary muscle 42 and/or the secondpapillary muscle 44 being penetrated such that the port 186 ispositioned adjacent the outer surface of the first papillary muscle 42and/or the second papillary muscle 44 being penetrated.

In an alternative configuration of the mitral regurgitation treatmentsystem, the mitral regurgitation treatment system may include anintermediate sheath 280 slidably disposed within the lumen of the outersheath 100. The intermediate sheath 280 may include a proximal portiondisposed adjacent the proximal end of the outer sheath 100, a devicelumen 284 extending to a distal end 282 of the intermediate sheath 280,and an anchoring lumen 288 extending to the distal end 282 of theintermediate sheath 280. The intermediate sheath 280 may include a port286 extending through a side wall of the device lumen 284 and/or througha side wall of the intermediate sheath 280 proximate the distal end 282of the intermediate sheath 280.

In at least some embodiments, the distal end 282 of the intermediatesheath 280 may be a closed distal end. The inner sheath 130 may beslidably disposed within the device lumen 284 of the intermediate sheath280. In at least some embodiments, the device lumen 284 of theintermediate sheath 280 and/or the port 286 of the intermediate sheath280 may be configured to direct the distal end 132 of the inner sheath130 toward and/or into contact with the first papillary muscle 42 and/orthe second papillary muscle 44 upon advancement of the inner sheath 130relative to the intermediate sheath 280. In some embodiments, theintermediate sheath 280 may be configured to cooperate with the innersheath 130 to facilitate penetration of an anchor into the firstpapillary muscle 42 and/or the second papillary muscle 44 through anopening at the distal end 132 of the inner sheath 130 at an anglegenerally perpendicular to a surface of the first papillary muscle 42and/or the second papillary muscle 44 being penetrated, as discussedherein. In at least some embodiments, a central longitudinal axis of theintermediate sheath 280 may be oriented substantially parallel to theouter surface of the first papillary muscle 42 and/or the secondpapillary muscle 44 being penetrated such that the port 286 ispositioned adjacent the outer surface of the first papillary muscle 42and/or the second papillary muscle 44 being penetrated. Additionally,the intermediate sheath 280 may be configured to be positioned with thedistal end 282 of the intermediate sheath 280 proximate and/or adjacentto a wall of the heart 10, as seen in FIG. 11 for example.

In some embodiments, the intermediate sheath 280 may include a tissuegrasping mechanism 290 disposed at and/or extendable from the anchoringlumen 288 and/or the distal end 282 of the intermediate sheath 280, asseen in FIG. 12 for example. It should be understood that while aspectsof the tissue grasping mechanism 290 is illustrated with respect to thefirst papillary muscle 42 in the interest of brevity, any and/or allaspects of the tissue grasping mechanism 290 may apply equally withrespect to the second papillary muscle 44 and/or any procedures ormethod steps occurring with respect thereto.

In contrast to the tissue grasping mechanism 120/220/320 discussedabove, the tissue grasping mechanism 290 may be configured to secure thedistal end 282 of the intermediate sheath 280 relative to the wall ofthe heart 10 and/or the first papillary muscle 42 and/or the secondpapillary muscle 44 being penetrated. In some embodiments, the tissuegrasping mechanism 290 may comprise a stabilizing needle configured toproject distally from and/or configured to be extended out of theanchoring lumen 288 and/or the distal end 282 of the intermediate sheath280 and into the wall of the heart 10 and/or a base of the firstpapillary muscle 42 and/or the second papillary muscle 44 beingpenetrated, as shown in FIG. 12 . After extending the tissue graspingmechanism 290 and/or the stabilizing needle into the wall of the heart10 and/or the base of the first papillary muscle 42 and/or the secondpapillary muscle 44 being penetrated, the inner sheath 130 may beadvanced distally relative to the intermediate sheath 280 and out of theport 286 and the distal end 132 of the inner sheath 130 may be advancedinto contact and/or abutment with the first papillary muscle 42 and/orthe second papillary muscle 44 to facilitate penetration of the anchorinto the first papillary muscle 42 and/or the second papillary muscle 44through the opening at the distal end 132 of the inner sheath 130 at anangle generally perpendicular to the surface of the first papillarymuscle 42 and/or the second papillary muscle 44 being penetrated, asdiscussed herein.

In an alternative configuration, the intermediate sheath 280 may includea tissue grasping mechanism 294 disposed at and/or extendable from theanchoring lumen 288 and/or the distal end 282 of the intermediate sheath280, as seen in FIG. 13 for example. It should be understood that whileaspects of the tissue grasping mechanism 294 is illustrated with respectto the first papillary muscle 42 in the interest of brevity, any and/orall aspects of the tissue grasping mechanism 294 may apply equally withrespect to the second papillary muscle 44 and/or any procedures ormethod steps occurring with respect thereto.

In contrast to the tissue grasping mechanism 120/220/320 discussedabove, the tissue grasping mechanism 294 may be configured to secure thedistal end 282 of the intermediate sheath 280 relative to the wall ofthe heart 10 and/or the first papillary muscle 42 and/or the secondpapillary muscle 44 being penetrated, similar to the tissue graspingmechanism 290 discussed above. In some embodiments, the tissue graspingmechanism 294 may comprise a suction member configured to projectdistally from and/or configured to be extended out of the anchoringlumen 288 and/or the distal end 282 of the intermediate sheath 280 andinto contact with the wall of the heart 10 and/or a base of the firstpapillary muscle 42 and/or the second papillary muscle 44 beingpenetrated, as shown in FIG. 13 . The tissue grasping mechanism 294and/or the suction member may expand radially outward in a distaldirection, and the tissue grasping mechanism 294 and/or the suctionmember may have a generally conical or trumpet-like shape expanding to agreater outer extent further from the distal end 282 of the intermediatesheath 280.

After extending the tissue grasping mechanism 294 and/or the suctionmember into contact with the wall of the heart 10 and/or the base of thefirst papillary muscle 42 and/or the second papillary muscle 44 beingpenetrated, suction and/or negative pressure may be applied to theanchoring lumen 288 and/or the tissue grasping mechanism 294 and/or thesuction member, thereby securing the tissue grasping mechanism 294and/or the suction member and/or the intermediate sheath 280 to the wallof the heart 10 and/or the base of the first papillary muscle 42 and/orthe second papillary muscle 44 being penetrated. Subsequently, the innersheath 130 may be advanced distally relative to the intermediate sheath280 and out of the port 286 and the distal end 132 of the inner sheath130 may be advanced into contact and/or abutment with the firstpapillary muscle 42 and/or the second papillary muscle 44 to facilitatepenetration of the anchor into the first papillary muscle 42 and/or thesecond papillary muscle 44 through the opening at the distal end 132 ofthe inner sheath 130 at an angle generally perpendicular to the surfaceof the first papillary muscle 42 and/or the second papillary muscle 44being penetrated, as discussed herein.

Additionally, in at least some embodiments, the inner sheath 130 mayinclude at least one orientation marker 138 positioned adjacent the port136 for determining an orientation of the port 136 relative to the firstpapillary muscle 42 and/or the second papillary muscle 44, as seen inFIGS. 14 and 15 . While not discussed in detail, it is contemplated thatthe positioning sheath 180 and/or the intermediate sheath 280 maysimilarly include at least one orientation marker 138 positionedadjacent the port 186 and/or the port 286, respectively, for determiningan orientation of the portion 186/286 relative to the first papillarymuscle 42 and/or the second papillary muscle 44, and any discussionrelated to the at least one orientation marker 138 and/or the port 136may be applied equally to any and/or all embodiments having a port(e.g., 186, 286) through a side wall of a sheath or lumen.

In some embodiments, the at least one orientation marker 138 may beradiopaque for identification during imaging. In some embodiments, theat least one orientation marker 138 may comprise and/or may be a singleorientation marker 138 framing or outlining the port 136 as viewed froma side of the inner sheath 130, as shown in FIG. 14 . The at least oneorientation marker 138 may be distinguishable under imaging to determinethe position of the inner sheath 130 and the port 136 relative to thefirst papillary muscle 42 and/or the second papillary muscle 44. Forexample, the at least one orientation marker 138 may include three sidesor legs, wherein a longest side or leg of the at least one orientationmarker 138 may be oriented parallel with the central longitudinal axisof the inner sheath 130, and a shorter pair of sides or legs of the atleast one orientation marker 138 may be oriented transversely relativeto the central longitudinal axis of the inner sheath 130.

In an alternative configuration, the at least one orientation marker 138may comprise and/or may be three or more individual orientation markers138 framing or outlining the port 136 as viewed from the side of theinner sheath 130, as shown in FIG. 15 . The at least one orientationmarker 138 may be distinguishable under imaging to determine theposition of the inner sheath 130 and the port 136 relative to the firstpapillary muscle 42 and/or the second papillary muscle 44. For example,one orientation marker 138 may be disposed on and/or within the sidewall of the inner sheath 130 opposite the port 136, which two or moreorientation markers 138 may be disposed on and/or within the side wallof the inner sheath 130 adjacent to and/or around an edge orcircumference of the port 136. Other orientation markerconfigurations—for example, L-shaped, circular, etc.—are alsocontemplated.

FIGS. 16 and 17 illustrate an example of a first/second anchor 140/150suitable for use with the disclosed mitral regurgitation treatmentsystem(s). It shall be understood that the first/second anchor 140/150may be used with any and/or all of the devices disclosed herein, as wellas others. Furthermore, one or more additional anchors may be used insome embodiments. The first/second anchor 140/150 may include an eyelet142/152 and a plurality of anchor legs 144/154 extending from the eyelet142/152. In at least some embodiments, the plurality of anchor legs144/154 may extend from the eyelet 142/152 to free ends 148/158, thefree ends 148/158 each having a tip configured to penetrate tissue. Insome embodiments, the tip of each free end 148/158 may be pointed and/orsharpened to easily pierce tissue. In some embodiments, the tip of eachfree end 148/158 may be slightly rounded, but still capable of easilypiercing tissue without tearing said tissue. Combinations and/or otherconfigurations of the tip are also contemplated. The first/second anchor140/150 may be configured to penetrate and secure to the first papillarymuscle 42 and/or the second papillary muscle 44.

The first/second anchor 140/150 and/or the plurality of anchor legs144/154 may be configured to shift from a delivery configuration whenconstrained by the inner sheath 130, wherein the plurality of anchorlegs 144/154 is generally straightened and extends longitudinally awayfrom the eyelet 142/152 in a first direction, and a deployedconfiguration when unconstrained by the inner sheath 130, wherein theplurality of anchor legs 144/154 extends in the first direction awayfrom the eyelet 142/152 and then curves back on itself at a bendlocation 146/156 to extend in a second direction opposite the firstdirection from the bend location 146/156 to free ends 148/158. In atleast some embodiments, the first direction may be a distal directionand the second direction may be a proximal direction. In someembodiments, the plurality of anchor legs 144/154 may extend in thesecond direction from the bend location 146/156 until the tip of eachfree end 148/158 is proximate to the eyelet 142/152 in the deployedconfiguration. For example, in the delivery configuration, the free ends148/158 of the plurality of anchor legs 144/154 may point in a distaldirection, and in the deployed configuration, the free ends 148/158 ofthe plurality of anchor legs 144/154 may point in a proximal direction.

In some embodiments, the first/second anchor 140/150 may be biasedtowards the deployed configuration when unconstrained. In someembodiments, the first/second anchor 140/150 may be self-biased towardsthe deployed configuration with unconstrained. In at least someembodiments, the first/second anchor 140/150 may be formed from a shapememory material. Some suitable but non-limiting materials for thefirst/second anchor 140/150, for example metallic materials, polymermaterials, composite materials, synthetic materials, etc., are describedbelow.

As shown in FIG. 16 , the mitral regurgitation treatment system maycomprise an inner sheath 130 including a first anchor 140 disposedwithin a lumen of an inner sheath 130 in the delivery configuration. Thefirst anchor 140 may be configured to penetrate and secure to the firstpapillary muscle 42. In at least some embodiments, the mitralregurgitation treatment system may include a pusher member 160 (shown inFIG. 16 in phantom) slidably disposed within the lumen of the innersheath 130. The pusher member 160 may be configured to expel the firstanchor 140 from the lumen of the inner sheath 130 and/or to push/urgethe first anchor 140 into the first papillary muscle 42. In someembodiments, a proximal portion and/or the eyelet 142 of the firstanchor 140 may be disposed within a lumen of the pusher member 160 inthe delivery configuration. The tissue grasping mechanism 120/220/320may be configured to hold and stabilize the first papillary muscle 42for penetration and securement of the first anchor 140 to the firstpapillary muscle 42. The inner sheath 130 may further include atethering element 170 disposed within the lumen of the inner sheath 130and/or within a lumen of the pusher member 160. The tethering element170 may engage with and/or be attached to the eyelet 142 of the firstanchor 140. The tethering element 170 may extend proximally from theeyelet 142 of the first anchor 140. The tethering element 170 may takeone or more of various forms known in the art—including, but not limitedto, a suture, a filament, a wire, etc.

The inner sheath 130 may be configured to extend and/or be advanceddistally out of the distal end 112 of the intermediate sheath 110 andinto contact and/or engagement with the first papillary muscle 42 and/orthe second papillary muscle 44. The inner sheath 130 may be configuredto extend and/or be advanced distally out of the distal end 112 of theintermediate sheath 110 while the tissue grasping mechanism120/220/320/290/294 holds and stabilizes the first papillary muscle 42and/or the second papillary muscle 44 and/or the distal end 282 of theintermediate sheath 280 to ensure proper positioning of a distal end 132of the inner sheath 130 relative to the first papillary muscle 42 and/orthe second papillary muscle 44 (e.g., FIGS. 4, 6, and 8-13 ). Uponexiting the inner sheath 130, the first anchor 140 may be configured toshift toward the deployed configuration, shown in FIG. 17 for example.

In some embodiments, the inner sheath 130 may further include a secondanchor 150 advanceable through the lumen of the inner sheath 130. Thesecond anchor 150 may be configured to penetrate and secure to thesecond papillary muscle 44. The tissue grasping mechanism120/220/320/290/294 may be configured to hold and stabilize the secondpapillary muscle 44 and/or the distal end 282 of the intermediate sheath280 for penetration and securement of the second anchor 150 to thesecond papillary muscle 44. In some embodiments, the first anchor 140and the second anchor 150 may be advanceable through the inner sheath130 in series. In some embodiments, the first anchor 140 and the secondanchor 150 may be advanceable through the inner sheath 130 in parallel.In some embodiments, the first anchor 140 and the second anchor 150 maybe advanceable through the inner sheath 130 separately. In someembodiments, the first anchor 140 and the second anchor 150 may beadvanceable through the inner sheath 130 together.

The first anchor 140 and the second anchor 150 may be connectable toeach other. In some embodiments, the first anchor 140 and the secondanchor 150 may be configured to be connected to each other afterdeployment from the inner sheath 130. In some embodiments, the firstanchor 140 and the second anchor 150 may be connected to each other bythe tethering element 170. The tethering element 170 may engage withand/or be attached to the eyelet 152 of the second anchor 150. Thetethering element 170 may extend proximally from the eyelet 152 of thesecond anchor 150. In some embodiments, the tethering element 170 may beconfigured to extend between the first papillary muscle 42 and thesecond papillary muscle 44, and/or the eyelet 142 of the first anchor140 and the eyelet 152 of the second anchor 150, in tension. In someembodiments, at least a portion of each of the first anchor 140 and thesecond anchor 150 is configured to extend transversely relative to thetethering element 170 when unconstrained by the inner sheath 130. Insome embodiments, the first anchor 140 and the second anchor 150 mayeach include a separate and/or independent tethering element, and theseparate and/or independent tethering elements may be connectabletogether. For example, the tethering element of the first anchor 140 maybe connectable to the tethering element of the second anchor 150, suchas by tying, adhesive(s), or other suitable means.

FIG. 18 illustrates an alternative first/second anchor 240/250 disposedwithin the lumen of the inner sheath 130 in a delivery configuration.The distal end 132 of the inner sheath 130 may be configured topenetrate the first papillary muscle 42 and/or the second papillarymuscle 44 in order to deploy the first/second anchor 240/250. In thedelivery configuration, the first/second anchor 240/250 may be orientedgenerally parallel to a central longitudinal axis of the inner sheath130 and/or generally perpendicular to the outer surface of the firstpapillary muscle 42 and/or the second papillary muscle 44.Alternatively, the first/second anchor 240/250 may be shaped and/orconfigured to pierce tissue as the first/second anchor 240/250 isadvanced out of the distal end 132 of the inner sheath 130. Somesuitable but non-limiting materials for the first/second anchor 240/250,for example metallic materials, polymer materials, composite materials,synthetic materials, etc., are described below.

A pusher member 260 may be slidably disposed within the lumen of theinner sheath 130. In some embodiments, the pusher member 260 may be anelongate solid rod or shaft, however, other configurations are alsocontemplated. The pusher member 260 may be configured to expel thefirst/second anchor 240/250 from the lumen of the inner sheath 130.After exiting the lumen of the inner sheath 130, the first/second anchor240/250 may be configured to shift to a deployed configuration, whereinthe first/second anchor 240/250 is oriented generally perpendicular tothe central longitudinal axis of the inner sheath 130 and/or generallyparallel to and/or abutting the outer surface of the first papillarymuscle 42 and/or the second papillary muscle 44. The tethering element170 may extend from an eyelet 242/252 of the first/second anchor240/250. Upon deployment, the tethering element 170 may extend throughthe first papillary muscle 42 and/or the second papillary muscle 44. Insome embodiments, the tethering element 170 may be configured to extendbetween the first papillary muscle 42 and the second papillary muscle44, and/or the first anchor 240 and the second anchor 250, in tension.In some embodiments, the tethering element 170 may be configured toextend between the eyelet 242 of the first anchor 240 and the eyelet 252of the second anchor 250, in tension. In some embodiments, at least aportion of each of the first anchor 240 and the second anchor 250 isconfigured to extend transversely relative to the tethering element 170when unconstrained by the inner sheath 130. In some embodiments, thefirst anchor 240 and the second anchor 250 may each include a separateand/or independent tethering element, and the separate and/orindependent tethering elements may be connectable together. For example,the tethering element of the first anchor 240 may be connectable to thetethering element of the second anchor 250, such as by tying,adhesive(s), or other suitable means.

A method for treating mitral regurgitation may include advancing thedistal end 102 of the outer sheath 100 intravascularly to the leftventricle 40 of the heart 10, as shown in FIG. 2 and described herein.The distal end 102 of the outer sheath 100 may be positioned proximatethe first papillary muscle 42. The method may include advancing theintermediate sheath 110/280 and/or the tissue grasping mechanism120/220/320/290/294 out of the distal end 102 of the outer sheath 100and into engagement with the first papillary muscle 42. The method mayinclude grasping the first papillary muscle 42 of the left ventricle 40using the tissue grasping mechanism 120/220/320/290/294, the tissuegrasping mechanism 120/220/320/290/294 being configured to hold andstabilize the first papillary muscle 42 for penetration of the firstanchor 140/240 into the first papillary muscle 42 from the inner sheath130, the inner sheath 130 being slidably disposed within the lumen ofthe intermediate sheath 110/280.

In some embodiments, the method may include advancing the inner sheath130 through the lumen of the intermediate sheath 110/280 and/or out ofthe distal end 112/282 of the intermediate sheath 110/280 proximate thefirst papillary muscle 42 while the tissue grasping mechanism120/220/320/290/294 holds and stabilizes the first papillary muscle 42relative to the outer sheath 100 and/or a wall of the left ventricle 40.The method may include advancing the first anchor 140/240 into the firstpapillary muscle 42 from within a lumen of the inner sheath 130, thefirst anchor 140/240 being configured to penetrate and secure to thefirst papillary muscle 42 of the left ventricle 40. The tetheringelement 170 may extend from the first anchor 140/240 into the distal end132 of the inner sheath 130 and/or the distal end 102 of the outersheath 100. The method may include releasing the first papillary muscle42 of the left ventricle 40 from the tissue grasping mechanism120/220/320/290/294 and/or withdrawing the tissue grasping mechanism120/220/320/290/294 and/or the intermediate sheath 110/280 into thedistal end 102 of the outer sheath 100, as seen in FIG. 19 for example.

The method may include repositioning the distal end 102 of the outersheath 100 adjacent the second papillary muscle 44 of the left ventricle40, as shown in FIG. 20 . The method may include advancing theintermediate sheath 110/280 and/or the tissue grasping mechanism120/220/320/290/294 out of the distal end 102 of the outer sheath 100and into engagement with the second papillary muscle 44. The method mayinclude grasping the second papillary muscle 44 of the left ventricle 40using the tissue grasping mechanism 120/220/320/290/294, the tissuegrasping mechanism 120/220/320/290/294 being configured to hold andstabilize the second papillary muscle 44 for penetration of the secondanchor 150/250 into the second papillary muscle 44 from the inner sheath130.

In some embodiments, the method may include advancing the inner sheath130 through the lumen of the intermediate sheath 110/280 and/or out ofthe distal end 112 of the intermediate sheath 110 proximate the secondpapillary muscle 44 while the tissue grasping mechanism120/220/320/290/294 holds and stabilizes the second papillary muscle 44relative to the outer sheath 100 and/or a wall of the left ventricle 40.The method may include advancing the second anchor 150/250 into thesecond papillary muscle 44 from within a lumen of the inner sheath 130,the second anchor 150/250 being configured to penetrate and secure tothe second papillary muscle 44 of the left ventricle 40. The tetheringelement 170 may extend from the second anchor 150/250 into the distalend 132 of the inner sheath 130 and/or the distal end 102 of the outersheath 100, and/or the tethering element 170 may extend between thefirst anchor 140/240 and the second anchor 150/250. The method mayinclude releasing the second papillary muscle 44 of the left ventricle40 from the tissue grasping mechanism 120/220/320/290/294 and/orwithdrawing the tissue grasping mechanism 120/220/320/290/294 and/or theintermediate sheath 110/280 into the distal end 102 of the outer sheath100, as seen in FIG. 21 for example.

In some embodiments, the method may include translating the firstpapillary muscle 42 closer to the second papillary muscle 44 bytensioning the tethering element 170 between the first anchor 140/240and the second anchor 150/250, as seen in FIG. 22 . In some embodiments,the mitral regurgitation treatment system the tethering element 170 maydraw, translate, and/or relocate the first papillary muscle 42 intocontact with the second papillary muscle 44. For example, in someembodiments, a space between the first papillary muscle 42 and thesecond papillary muscle 44 may be eliminated and/or reduced to zero.This arrangement and/or configuration may be equally applied to anyconfiguration and/or embodiment disclosed herein.

In some embodiments, the method may include connecting the tetheringelement of the first anchor 140/240 to the tethering element of thesecond anchor 140/240, as discussed herein, such as by tying thetethering element of the first anchor 140/240 together with thetethering element of the second anchor 140/240, or by fixing thetethering element of the first anchor 140/240 to the tethering elementof the second anchor 140/240 with an adhesive, or by other suitablemeans.

The materials that can be used for the various components of the outersheath 100, the intermediate sheath 110/280, the tissue graspingmechanism 120/220/320/290/294, the inner sheath 130, the first anchor140/240, the second anchor 150/250, the pusher member 160/260, thetethering element 170, the positioning sheath 180, etc. (and/or othersystems or components disclosed herein) and the various elements thereofdisclosed herein may include those commonly associated with medicaldevices. For simplicity purposes, the following discussion makesreference to the outer sheath 100, the intermediate sheath 110/280, thetissue grasping mechanism 120/220/320/290/294, the inner sheath 130, thefirst anchor 140/240, the second anchor 150/250, the pusher member160/260, the tethering element 170, the positioning sheath 180, etc.However, this is not intended to limit the devices and methods describedherein, as the discussion may be applied to other elements, members,components, or devices disclosed herein, such as, but not limited to,the first prong 122/222, the second prong 124/224, the curved member322, the plurality of anchor legs 144/154, etc. and/or elements orcomponents thereof.

In some embodiments, the outer sheath 100, the intermediate sheath110/280, the tissue grasping mechanism 120/220/320/290/294, the innersheath 130, the first anchor 140/240, the second anchor 150/250, thepusher member 160/260, the tethering element 170, the positioning sheath180, etc., and/or components thereof may be made from a metal, metalalloy, polymer (some examples of which are disclosed below), ametal-polymer composite, ceramics, combinations thereof, and the like,or other suitable material. Some examples of suitable metals and metalalloys include stainless steel, such as 444V, 444L, and 314LV stainlesssteel; mild steel; nickel-titanium alloy such as linear-elastic and/orsuper-elastic nitinol; other nickel alloys such asnickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;platinum; palladium; gold; combinations thereof; and the like; or anyother suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear than the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also be distinguished based on its composition), whichmay accept only about 0.2 to 0.44 percent strain before plasticallydeforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Other suitable materials may include ULTANIUM™(available from Neo-Metrics) and GUM METAL™ (available from Toyota). Insome other embodiments, a superelastic alloy, for example a superelasticnitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the outer sheath 100,the intermediate sheath 110/280, the tissue grasping mechanism120/220/320/290/294, the inner sheath 130, the first anchor 140/240, thesecond anchor 150/250, the pusher member 160/260, the tethering element170, the positioning sheath 180, etc., and/or components thereof, mayalso be doped with, made of, or otherwise include a radiopaque material.Radiopaque materials are understood to be materials capable of producinga relatively bright image on a fluoroscopy screen or another imagingtechnique during a medical procedure. This relatively bright image aidsa user in determining the location of the outer sheath 100, theintermediate sheath 110/280, the tissue grasping mechanism120/220/320/290/294, the inner sheath 130, the first anchor 140/240, thesecond anchor 150/250, the pusher member 160/260, the tethering element170, the positioning sheath 180, etc. Some examples of radiopaquematerials can include, but are not limited to, gold, platinum,palladium, tantalum, tungsten alloy, polymer material loaded with aradiopaque filler, and the like. Additionally, other radiopaque markerbands and/or coils may also be incorporated into the design of the outersheath 100, the intermediate sheath 110/280, the tissue graspingmechanism 120/220/320/290/294, the inner sheath 130, the first anchor140/240, the second anchor 150/250, the pusher member 160/260, thetethering element 170, the positioning sheath 180, etc. to achieve thesame result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the outer sheath 100, the intermediatesheath 110/280, the tissue grasping mechanism 120/220/320/290/294, theinner sheath 130, the first anchor 140/240, the second anchor 150/250,the pusher member 160/260, the tethering element 170, the positioningsheath 180, etc. For example, the outer sheath 100, the intermediatesheath 110/280, the tissue grasping mechanism 120/220/320/290/294, theinner sheath 130, the first anchor 140/240, the second anchor 150/250,the pusher member 160/260, the tethering element 170, the positioningsheath 180, etc., and/or components or portions thereof, may be made ofa material that does not substantially distort the image and createsubstantial artifacts (e.g., gaps in the image). Certain ferromagneticmaterials, for example, may not be suitable because they may createartifacts in an MM image. The outer sheath 100, the intermediate sheath110/280, the tissue grasping mechanism 120/220/320/290/294, the innersheath 130, the first anchor 140/240, the second anchor 150/250, thepusher member 160/260, the tethering element 170, the positioning sheath180, etc., or portions thereof, may also be made from a material thatthe MM machine can image. Some materials that exhibit thesecharacteristics include, for example, tungsten,cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g.,UNS: R44035 such as MP35-N® and the like), nitinol, and the like, andothers.

In some embodiments, the outer sheath 100, the intermediate sheath110/280, the tissue grasping mechanism 120/220/320/290/294, the innersheath 130, the first anchor 140/240, the second anchor 150/250, thepusher member 160/260, the tethering element 170, the positioning sheath180, etc., and/or portions thereof, may be made from or include apolymer or other suitable material. Some examples of suitable polymersmay include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene(ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, forexample, DELRIN® available from DuPont), polyether block ester,polyurethane (for example, Polyurethane 85A), polypropylene (PP),polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester basedcopolymers (for example, butylene/poly(alkylene ether) phthalate and/orother polyester elastomers such as HYTREL® available from DuPont),polyamide (for example, DURETHAN® available from Bayer or CRISTAMID®available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, polyurethane silicone copolymers (forexample, ElastEon® from Aortech Biomaterials or ChronoSil® fromAdvanSource Biomaterials), biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments, the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the outer sheath 100, the intermediate sheath110/280, the tissue grasping mechanism 120/220/320/290/294, the innersheath 130, the first anchor 140/240, the second anchor 150/250, thepusher member 160/260, the tethering element 170, the positioning sheath180, etc. may include and/or be formed from a textile material. Someexamples of suitable textile materials may include synthetic yarns thatmay be flat, shaped, twisted, textured, pre-shrunk or un-shrunk.Synthetic biocompatible yarns suitable for use in the present inventioninclude, but are not limited to, polyesters, including polyethyleneterephthalate (PET) polyesters, polypropylenes, polyethylenes,polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides,naphthalene dicarboxylene derivatives, natural silk, andpolytetrafluoroethylenes. Moreover, at least one of the synthetic yarnsmay be a metallic yarn or a glass or ceramic yarn or fiber. Usefulmetallic yarns include those yarns made from or containing stainlesssteel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-based alloy. Theyarns may further include carbon, glass or ceramic fibers. Desirably,the yarns are made from thermoplastic materials including, but notlimited to, polyesters, polypropylenes, polyethylenes, polyurethanes,polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns maybe of the multifilament, monofilament, or spun-types. The type anddenier of the yarn chosen may be selected in a manner which forms abiocompatible and implantable prosthesis and, more particularly, avascular structure having desirable properties.

In some embodiments, the outer sheath 100, the intermediate sheath110/280, the tissue grasping mechanism 120/220/320/290/294, the innersheath 130, the first anchor 140/240, the second anchor 150/250, thepusher member 160/260, the tethering element 170, the positioning sheath180, etc. may include and/or be treated with a suitable therapeuticagent. Some examples of suitable therapeutic agents may includeanti-thrombogenic agents (such as heparin, heparin derivatives,urokinase, and PPack (dextrophenylalanine proline argininechloromethylketone)); anti-proliferative agents (such as enoxaparin,angiopeptin, monoclonal antibodies capable of blocking smooth musclecell proliferation, hirudin, and acetylsalicylic acid);anti-inflammatory agents (such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine);antineoplastic/antiproliferative/anti-mitotic agents (such aspaclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine,epothilones, endostatin, angiostatin and thymidine kinase inhibitors);anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine);anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGDpeptide-containing compound, heparin, anti-thrombin compounds, plateletreceptor antagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, andtick antiplatelet peptides); vascular cell growth promoters (such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promoters); vascular cellgrowth inhibitors (such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin); cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vascoactivemechanisms.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A method for treating mitral regurgitation,comprising: advancing a distal end of an outer sheath intravascularly toa left ventricle of a heart, the outer sheath having a lumen extendingto the distal end of the outer sheath; wherein an intermediate sheath isslidably disposed within the lumen of the outer sheath, the intermediatesheath having a lumen extending to a distal end of the intermediatesheath and a tissue grasping mechanism disposed at the distal end of theintermediate sheath; and wherein an inner sheath is slidably disposedwithin the lumen of the intermediate sheath; grasping a first papillarymuscle of the left ventricle using the tissue grasping mechanism, thetissue grasping mechanism being configured to hold and stabilize thefirst papillary muscle for penetration of a first anchor into the firstpapillary muscle from the inner sheath; advancing the first anchor intothe first papillary muscle from within a lumen of the inner sheath, thefirst anchor being configured to penetrate and secure to the firstpapillary muscle of the left ventricle; grasping a second papillarymuscle of the left ventricle using the tissue grasping mechanism at thedistal end of the intermediate sheath, the tissue grasping mechanismbeing configured to hold and stabilize the second papillary muscle forpenetration of a second anchor into the second papillary muscle from theinner sheath; advancing the second anchor into the second papillarymuscle from within the lumen of the inner sheath, the second anchorbeing configured to penetrate and secure to the second papillary muscleof the left ventricle; and releasing the second papillary muscle fromthe tissue grasping mechanism, wherein a tethering element extends fromthe first anchor to the second anchor to connect and reposition thefirst papillary muscle relative to the second papillary muscle.
 2. Themethod of claim 1, wherein the first anchor and the second anchor eachinclude an eyelet, and the tethering element extends between the eyeletof the first anchor and the eyelet of the second anchor.
 3. The methodof claim 2, wherein at least a portion of each of the first anchor andthe second anchor is configured to extend transversely relative to thetethering element when unconstrained by the inner sheath.
 4. The methodof claim 2, wherein at least one of the first anchor and the secondanchor includes a plurality of anchor legs extending from the eyelet tofree ends, wherein the plurality of anchor legs is configured to shiftfrom a delivery configuration when constrained by the inner sheath to adeployed configuration when unconstrained by the inner sheath; whereinin the delivery configuration the free ends of the plurality of anchorlegs point in a distal direction, and in the deployed configuration thefree ends of the plurality of anchor legs point in a proximal direction.5. The method of claim 2, wherein the method further includes:translating the first papillary muscle closer to the second papillarymuscle by tensioning the tethering element between the first anchor andthe second anchor.